Zadaxin is generally well tolerated. During clinical studies involving >2000 individuals distributed over all age groups, no clinically significant adverse reactions attributable to thymosin α1 administration were reported (see table).
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Immune Disorders: Autoimmune liver disease and primary immune deficiency.
Adverse experiences have been infrequent and mild, consisting primarily of local discomfort at the injection site and rare instances of erythema. Transient muscle atrophy, polyarthralgia with hand edema and rash at the injection site. As with any new drug, it is possible that expanded commercial use of the drug could reveal rare adverse reactions not observed in clinical studies. A transient increase in ALT to more than twice baseline value (flare) can occur during Zadaxin therapy for chronic hepatitis B. When ALT flare occurs, Zadaxin should generally be continued unless signs and symptoms of liver failure are observed.